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Microbiome in Transplant and Cellular Therapy Outcomes.

Gastrointestinal microbiome influences health outcomes in patients undergoing Transplantation and Cellular Therapy.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000374460
Acronym
micro TCT
Enrollment
250
Registered
2025-04-28
Start date
2025-05-05
Completion date
2028-12-29
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will assess multiomics of intestinal microbial composition and the relationship with other metabolic components, including short-chain fatty acids (SCFA) and immune cell function, which will inform for improvements of health outcomes in Transplant and Cellular Therapy recipients.

Interventions

This observational study involves the collection from each time point (below): Blood samples, rectal swabs, frozen stool and bronchoalveolar lavage/ wash samples, processed and stored whole or as derivatives. To help us define the interaction between the microbiome and the outcomes of participants' transplant or cellular therapy. Clinical information and samples will be collected prospectively at the following timepoints for participants receiving Hematopoietic Stem Cell Transplantation (HSCT)

This observational study involves the collection from each time point (below): Blood samples, rectal swabs, frozen stool and bronchoalveolar lavage/ wash samples, processed and stored whole or as derivatives. To help us define the interaction between the microbiome and the outcomes of participants' transplant or cellular therapy. Clinical information and samples will be collected prospectively at the following timepoints for participants receiving Hematopoietic Stem Cell Transplantation (HSCT): - The day of patients transplant (Day 0); - Day 14 post-transplant; - Day of hospital discharge; and - Day 100 Participants who receive HSCT, are also invited to undergo the optional PET-scan at Day 14-18 post-transplant, and may be invited for a repeat scan if they are readmitted with GVHD. Patients who receive Chimeric Antigen Receptor (CAR) T/Natural Killer (NK) cellular therapy will have samples collected: - Day of infusion; - Day 14; - Day 30 and; - Day 100 post-infusion For patients that receive Solid Organ Transplantation, will have samples collected: - Prior to their scheduled transplant (Day of Listing on this study) - Day of transplant; - Day of hospital discharge post-transplant; - Day 21 post-transplant procedure; - Day 90 post-transplant; - 6 months post-transplant; and - 12 months post-transplant Participants may also be invited to donate samples if they are readmitted to hospital with an infection, or GVHD. Participants enrolled in this study will also have clinical information collected (if consented) during their collection timepoints and at Month 6 and 12 post-transplant/infusion check-ups. This may include disease indication, characteristics of Transplant and Cellular Therapy (TCT), incidence of acute toxicities and disease response, and incidence of longer-term complications, survival and episodes of Infection, GVHD and organ rejection. As well as the collection of information regarding other indirect complications of TCT, including but not limited to GVHD, infectious complications, immunological complications, duration of hospitalization and use of concurrent medications

Sponsors

Metro North Hospital and Health Service (MNHHS)
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Age 18 years or older; - Able to provide voluntary informed consent; - Planned administration of allogeneic HSCT, CAR T/NK or SOT.

Exclusion criteria

1. Unwilling or unable to undertake specific components of the study, such as: - Venepuncture; - Provision of faecal specimens; - Rectal swab 2. Allergy/intolerance to FDG; these subjects may still be enrolled for specimen provision but abstain from the FDG-PET component.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026